The medical device development process has many important differences from the path for creating a new drug. In regulating new products, the U.S. Food and Drug Administration must take the unique nature of these devices into account. For organizations creating innovative medical products, it's vital to understand the role clinical trials play in obtaining FDA approval.

In an article published in the New England Journal of Medicine, Clinical Trials Director Dr. Owen Faris and Center for Devices and Radiological Health Director Dr. Jeffrey Shuren explained the FDA's current approach to clinical trials for medical devices. The officials provide insight into what it takes to go from developing a new product to receiving approval and bringing it to market. Strategically navigating theses steps can make all the difference in the successful launch of a device.

Clinical trials and medical devices

"The variety of medical devices impacts the FDA's perspective on clinical trials."

In the article, Faris and Shuren discussed how the wide variety of medical devices impacts the FDA's perspective on requiring clinical trials. Products that present a low level of risk to users are generally exempt from FDA review, while a moderate-risk one is most often cleared when the manufacturer demonstrates it is sufficiently similar to a device the FDA already approved. If, however, a device poses a high risk or is too novel to be simply cleared, the agency usually requires clinical evidence supporting its safety, effectiveness and proper use.

While the FDA most often requires pharmaceuticals to undergo long-term, double-blind, randomized trials, the means of testing devices tends to be more flexible. That's because conducting a large-scale study on many products, such as an implantable device, is not feasible. Faris spoke to TCTMD about why the FDA's position on device approvals is so different from the requirements for drugs.

"Device trials are unique in many ways and really require us to be very flexible in the kinds of data we see," he said.

Implications for future development

For the companies involved in medical device design and development, the FDA's attitude toward clinical trials can play a major role in how they move forward. The officers stated that, in some cases, it may be possible to establish the benefits and risks of a product by considering other sources of data. An existing registry, animal testing or a computer model could provide enough information for the agency to come to a decision.

For the FDA, it is important to take into account that not all products should be tested in the same ways. In many cases, an alternative to a double-blind study could be more practical and informative. The type of device and the medical rewards anticipated from having it available influence the kind of clinical evidence required. If a product is considered a breakthrough, expected to fill an otherwise unmet medical need that could have significant implications for patients, the agency may be willing to set it on the Expedited Access Pathway, moving forward with less complete evidence.

Manufacturers creating innovative medical devices need a strong awareness of how they will work through the FDA clearance or approval process. Developing an understanding of the way regulators understand the need for clinical trials for different kinds of devices is a good start.

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